Last updated on June 2020

An Efficacy Study Comparing Brigatinib Versus Alectinib in Advanced Anaplastic Lymphoma Kinase-Positive (ALK+) Non-Small-Cell Lung Cancer (NSCLC) Participants Who Have Progressed on Crizotinib

Brief description of study

The purpose of this study is to compare the efficacy of brigatinib versus alectinib in participants with ALK+ locally advanced or metastatic NSCLC who have progressed on crizotinib as evidenced by progression-free survival (PFS) as assessed by response evaluation criteria in solid tumors (RECIST) v1.1.

Detailed Study Description

The drug being tested in this study is called brigatinib. Brigatinib has been demonstrated to benefit people with ALK+ NSCLC.

The comparator drug is called alectinib. Alectinib has been demonstrated to benefit people with ALK+ NSCLC. Both drugs belong to a class of drugs called anaplastic lymphoma kinase (ALK) inhibitors. Both drugs are taken by mouth. Both drugs are approved by the United States Food and Drug Administration (US FDA).

The study will enroll approximately 246 participants. Participants will be randomly assigned (by chance, like flipping a coin) in 1:1 ratio to one of the two treatment groups:

  • Brigatinib
  • Alectinib

All participants will be asked to take brigatinib or alectinib at the same time each day throughout the study.

This multi-center trial will be conducted the United States, Argentina, Austria, Canada, Chile, China, Croatia, France, Germany, Greece, Hong Kong, Italy, Mexico, Romania, Russia, South Korea, Spain, Sweden, Taiwan, Thailand. The overall time to participate in this study is 5 years. Participants will make multiple visits to the clinic, and 30 days after last dose of study drug for a follow-up assessment.

Clinical Study Identifier: NCT03596866

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Virginia Cancer Specialists

Fairfax, VA United States
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Hopital Foch

Suresnes, France
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Gustave Roussy

Villejuif cedex, France
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Hopital Albert Michallon

Grenoble Cedex 9, France
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Queen Mary Hospital

Hong Kong, Hong Kong
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National Cancer Center

Goyang-si, Korea, Republic of
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Ajou University Hospital

Suwon, Korea, Republic of
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Ulsan University Hospital

Ulsan, Korea, Republic of
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Samsung Medical Center

Seoul, Korea, Republic of
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Medica Sur

Ciudad de Mexico, Mexico
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Saint-Petersburg, Russian Federation
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Moscow, Russian Federation
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Leningrad Regional Clinical Hospital

Saint Petersburg, Russian Federation
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Center of Palliative Medicine - Devita

Saint Petersburg, Russian Federation
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Klinikum Klagenfurt Am Worthersee

Klagenfurt am Wörthersee, Austria
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Clinica Ultra Sound Diagnostic 4D

Pyatigorsk, Russian Federation
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Recruitment Status: Open

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